Randomized Clinical Trial of Enamel Matrix Derivative: Radiographic Analysis
Summary
This is a split-mouth, double-blind randomized controlled trial. Computerized linear radiographic measurements were used to detect infrabony defects treated with open flap debridement (OFD) or OFD associated with enamel matrix derivative (EMD), after 24 months. Ten patients presenting 2 or more defects were selected (43 defects). An individualized film holder was used to take standardized radiographs at baseline and after 24 months. Images were digitized and used to measure the distances from the cemento-enamel junction (CEJ) to the alveolar crest (AC), CEJ to the bottom of the defect (BD) and infrabony defect angle.
Timeline
- Start
- 2002-06
- Primary completion
- 2004-10
- Completion
- 2005-10
Outcome
Missed primary endpoint
paper CONCLUSION: Linear radiographic analysis was not able to demonstrate superiority of EMD treated infrabony defects when compared to ODF after 24 months. PMID 25475143 ↗
Publications
- Results Chambrone D, Pasin IM, Chambrone L, Pannuti CM, Conde MC, Lima LA. Treatment of infrabony defects with or without enamel matrix proteins: a 24-month follow-up randomized pilot study. Quintessence Int. 2010 Feb;41(2):125-34.
- Results Chambrone D, Pasin IM, Conde MC, Panutti C, Carneiro S, Lima LA. Effect of enamel matrix proteins on the treatment of intrabony defects: a split-mouth randomized controlled trial study. Braz Oral Res. 2007 Jul-Sep;21(3):241-6. doi: 10.1590/s1806-83242007000300009.
- Ragghianti Zangrando MS, Chambrone D, Pasin IM, Conde MC, Pannuti CM, de Lima LA. Two-year randomized clinical trial of enamel matrix derivative treated infrabony defects: radiographic analysis. BMC Oral Health. 2014 Dec 4;14:149. doi: 10.1186/1472-6831-14-149.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | enamel matrix derivative | Protein / enzyme biologic | — | — |